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Our newsletters provide information on business management systems. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a subject of interest for a future newsletter, please let us know.

The Value of Accredited Certification

The International Accreditation Forum (IAF) recently undertook a global survey to capture market feedback on the value of certification. The results show that not only is certification being used as a tool to deliver internal business improvement and to meet regulatory compliance, but businesses confirm that it has a positive effect on revenue.

The survey, which was translated into 22 languages, was promoted in each economy by the accreditation and certification community, stakeholder groups and business intermediaries. Responses to the questions were not mandatory, and so the quoted percentages are based on the businesses that provided a response.

The main findings of the report showed:

Approximately 50% of the 4000 respondents, reported an increase in sales as a result of certification.
In terms of general added value, 80% felt that certification had given them real value.
Nearly 50% cited internal business improvement as the main reason for seeking certification.
An overwhelming number of respondents cited certification as being important to their customers.
80% reported that certification has helped them to meet national regulatory requirements.

Small business was the major contributor to this survey. Seventy-one percent of respondents work in organizations employing less than 249 people. The majority of businesses that responded have management systems certification, with 51% a quality management system, 18% environmental management.

Further tangible value respondents stated included:

47% of respondents stated that the primary driver was to improve internal business operations and processes.

89% confirmed that they commission the services of a certification body based intheir national economy.

62% of respondents confirmed that they strongly agreed or agreed that the certification process provided value for money.

60% of businesses used the services of an external consultant to support them through the certification process.

Businesses taking part also reported high levels of satisfaction with the certification process in terms of the timeframe to achieve certification and the competence of the assessment teams. Given these positive findings, businesses perceive accredited certification as providing value for money.

Read the complete IAF report here in PDF.

AS9101:20XX - Continued

In a prior newsletter this year, we provided information based on a recent workshop we attended conducted by National Quality Assurance (NQA) in Los Angeles, California. For our AS9100/10/9003 Aviation, Space and Defense organizations, and readers we want to share more of the information provided.

PEAR(s) will be mandatory and created for each top level process audited to AS91XX series requirements. No longer limited to processes associated with Product Realization requirements.
Improvement on “QMS Matrix Report”, “NCR” and “Audit Reports” will take place.
Incorporation of 9104/1 including Certification Structure will take place.
The names of the audit documents are changing from appendices to forms. This will improve process effectiveness.

Improvement of Forms to reflect OASIS entry requirements

New Process Evaluation Matrix (PEM).
Clear definitions to assist auditors when determining process effectiveness levels / numerical conclusions when documenting PEAR’s.

AS9110:2012

Client transition materials available on IAQG web site.
New AS9110 OER now available.
Requires CB reaccreditation.
Audits can occur after training, accreditation & auditor authentication.
All audits after 1/1/14 have to be to AS9110:2012.
Auditors have to complete webinar and submit to RABQSA.
All 9110 companies must be audited to this standards no later than 01 Jan 2014

….meaning all audits completed by 1 November 2013

AS9003 – Inspection and Test Quality System

New version now published.
To ensure that the inspection, conformity and airworthiness of products are maintained.
Based on the ISO 9002:1994 Quality Standard.
Contains the minimum requirements for an Inspection and Test Quality System.
Intended for use by small build/machine to print organizations.

Interested in more information on future changes, contact us.

Measurement Processes

All the quality processes in the world won’t help a company whose measuring equipment and measurement processes are out of control. In manufacturing, maintaining accuracy in measurement equipment is essential to ensuring a quality end product.

ISO 10012 specifies the requirements for an effective measurement management system that can be used by an organization performing measurements as part of the overall quality management system, and for ensuring that metrological requirements are met. To help users get the best out of the standard, the requirement clauses are followed by text boxes containing relevant guidance.

ISO 10012, Measurement management systems – Requirements for measurement processes and measuring equipment, can be used by organizations to meet the requirements for measurement and measurement process control in ISO management systems and ISO 14001:2004 Environmental management systems – although its use is not a requirement of either – or it can be implemented independently of these standards.

The standard will prove useful when customers and their suppliers need to specify product characteristics, as a technical reference underpinning legislation and regulations, and as a tool in assessment and auditing of management systems. However, its use in third- party certification is not a requirement, but a matter of agreement between the interested parties.

By merging the scopes of application of these earlier standards – equipment and processes – in a unique document and integrating the process-based approach of the ISO series, ISO 10012 constitutes a comprehensive “measurement management system”.

The ISO 10012 Standard can be purchasedthroughthe ISO Store.

In the News

ROI Evidence of Utilizing Quality Approaches

Have you ever wondered if there was ROI evidence that supports the use of quality professionals and implementations? A good way to find this sort of information is to use the Knowledge Center advanced search function. After searching Business Results, checking Assigned Keywords and Case Studies, it turns out there are a number of free case studies and articles relating to that very topic.

U.S. Manufacturing Technology Orders See 30% Monthly Gain

Manufacturing Technology Orders (USMTO) totaled $507.91 million, according to AMT-The Association for Manufacturing Technology. This total, as reported by companies participating in the USMTO program, was up 30.4 percent from February to March 2013.

The USMTO report, compiled by the trade association representing the production and distribution of manufacturing technology, provides regional and national U.S. orders data of domestic and imported machine tools and related equipment. Analysis of manufacturing technology orders provides a reliable leading economic indicator as manufacturing industries invest in capital metalworking equipment to increase capacity and improve productivity.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs. We offer group discounts.

ISO 9001 Quality Management

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100 Aviation, Space and Defense

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS 16949 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Phone: 888-572-9642 toll free

IS0 9001 Future Revision

Walter — Wed, 08 May 2013 17:10:25 +0000

Suggestions for Upcoming Revision

As most of us are aware of, ISO 9001 is in the process of being revised, with a planned release date of some time in 2015. More than three years ago, anticipating the eventuality of a revision, members of ISO Subcommittee 2 (SC 2)—the subcommittee that has responsibility for the revision and maintenance of ISO 9001—began conducting an extensive user survey.

Feedback was sought from every industry and sector, from users of other management system standards, and even from those who have chosen not to implement an ISO 9001-compliant quality management system (QMS). More than 10,000 responses were received from around the world. Many contained comments that needed to be translated. All these data were collated, reviewed, and analyzed. Overall, the consensus from respondents was that they felt the standard is good as it is, but it needs to be revised. There seemed to be little support for wholesale changes, or creating a hierarchical or tiered set of requirements standards similar to Capability Maturity Model Integration (CMMI).

The most commonly received comments from the extensive survey that SC 2 sent to ISO users related to the following:

Requests to include requirements relating to risk management, financial management, and change management
Requests for clarification of existing requirements relating to outsourcing, product realization, and the distinction between verification and validation
Some respondents voiced concern about the ease of use for service and software industry.

In the coming months, the output of the most recent meeting of the WG 24 will be released. The committee draft (CD) is expected to be for sale some time in June 2013. At that time, comments will be solicited to ensure that this revision perpetuates the high standard that has been the hallmark of ISO 9001 for more than a quarter of a century.

We will keep you informed on all future information on the ISO 9001 standard revision.

Creating Customer Value

Walter — Thu, 02 May 2013 23:25:44 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business May 2013

This Month

* Creating Customer Value

* User Friendly Form Design

* Auditing Analysis of Data

* In the News

* Training Courses

Events…

ASQ World Conference on Quality Improvement May 6-8, 2013 Indianapolis, IN.

2013 SME Conference June 2-4, 2013 Baltimore, MD

Helpful Links…

What We Do

Operational and Quality Systems
Training onsite and online
Lean Enterprise
Six Sigma
Kaizen Events
ITAR
NADCAP
Improved Profits and More!

Connect With Us

If you have any questions regarding the content or have a subject of interest for a future newsletter, please let us know.

Creating Customer Value

It appears from our vantage point and the experts that the manufacturing segment is coming back. Many of us are thinking of ways to best shape our company’s economic recovery into the most profitable form possible.

The answer is to deliver more than your share of customer value. Keep in mind your competition won’t be standing idle while you innovate and grow during the improving economy. To stay ahead of your competition, you should keep a strategic focus on what sets your company apart within your industry.

You could have a number of marketable differences from your competition. Spending more on R&D, or sales efforts? Acquiring capital equipment beyond your current capacities? Is what you’re doing focused on internal needs, or are you implementing your customer’s ideas?

1. Conduct face-to-face interviews.

Of all the ways to learn about customer needs-telephone, e-mail survey, Internet, nothing comes close in effectiveness to face-to-face customer interviews. Many of us use customer surveys to determine satisfaction levels. Many of use a Likert Scale method (1-5) based on questions we have determined are important.

The reality is that most questions asked are actually customer-reactive, not market-customer proactive interviews. Should we be asking our customers “Please rate the quality of our products?”, or “How can we provide a better quality product to you?” Get out and visit your customers and find out what’s important to them!

2. Develop a Voice of the Customer mentality.

Voice of the Customer studies typically consist of both qualitative and quantitative steps. They are generally conducted at the start or finish of a new product, process, or service design in order to better understand the customer’s wants and needs. That e-mail survey with the 3-5% average return, is it handing you a report of “what the customer wants?” This is a flawed model. Train your people to be VOC experts!

Best of all, you’ll develop a reputation among customers as “that supplier who really does listen to us.”

3. Become a quantitative organization.

After you conduct good qualitative customer interviews, you can target specific customer ideas you could work on. Which ideas do you target in your product design? Which ideas do you target in your product realization processes? At this point get quantitative. Being quantitative helps you to understand which customer outcomes are most important and least satisfied.

The key to taking advantage of the recovering economy is in changing the way your company approaches your current and future customers. Start now, with a new approach and you’ll shape a true recovery at your company.

User Friendly Form Design

Company user-friendly forms reduce operating time, expense and employee frustration. Here are nine tips for designing effective forms:

1. Name the form so its purpose is clear.Using non-specific terms may force users to spend extra time locating the form they need.

2. Maintain the expected order of fields. Use headers that are standard for your organization and sequence fields logically.

3. Position field names clearly with their corresponding fields. Don’t make users guess whether they need to write above a field name or below it.

4. Emphasize an often-overlooked field by surrounding it with extra space, using bolder text, or repositioning it to a more prominent location on the form.

5. Design the form to be clear without instructions.However, if instructions are required, place them on the form itself.

6. Design a single form for multiple use. If the same information is required for several different forms, consider consolidating the forms.

7. Identify each form with a number and revision date to ensure the most current version is being used.

8. Avoid referencing individuals’ names or telephone numbers, unless the form is online or otherwise economical to revise.

9. Automate where practical by creating computer-generated templates or implementing a “paperless” online forms system.

Auditing Analysis of Data

Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn’t examined, evaluated, analyzed, and converted into proposals for decision making.

The Guidance on Terminology resource at the ISO web site defines the term “analysis” as the breaking up of something complex into its various simple elements. The reason to separate something into its elements is to determine either their nature (qualitative analysis) or their proportions (quantitative analysis).

Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions.

As a result of the monitoring and measurement activities called for by ISO 9001:2008, Clauses 8.2.3 and 8.2.4, you will have collected a lot of data, which can be analyzed to indicate trends. Any trends you may find could suggest where there are problems in your quality management system and indicate areas where improvements are needed.

Analysis of data can help to determine the root cause of existing or potential problems, and thereby guide decisions about corrective and preventive actions need for improvement. For an effective evaluation by management of the total performance of an organization, data from all parts of the organization should be integrated and analyzed.

The overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis can be used to determine:

Trends; customer satisfaction (and satisfaction of other interested parties)
Process effectiveness and efficiency; supplier contribution
Success of performance improvement objectives
Economics of quality, financial, and market-related performance
Performance benchmarking; competitiveness.

In the News

Reshoring Report

Nearly half of U.S. manufacturing companies surveyed are thinking of reshoring jobs.

The MIT Forum for Supply Chain Innovation has released a report, “U.S Reshoring: A Turning Point,” based on the results of its 2012 U.S. reshoring survey.

In total, 340 participants completed the survey, of which 198 were manufacturing-only companies. Out of those 198 companies, 156 were U.S. companies, defined as having their headquarters in the United States. The top three manufacturing-only industries that responded to the survey were: computers and electronics (19.2 percent), food and beverage (10.6 percent) and chemicals (8.1 percent). The category, “Other Manufacturing Companies,” includes manufacturers of personal care products, golf equipment, and various other companies.

For U.S. manufacturing companies, the data indicates a significant disparity between companies that are “considering” vs. those that are “definitively” planning on re-shoring, meaning to bring their manufacturing activities back to the United States. This disparity was independent of company size.

Specifically, 33.6 percent of respondents stated that they are “considering” bringing manufacturing back to the United States, while only 15.3 percent of U.S. companies stated that they are “definitively” planning to reshore activities. Time-to-market and controlling costs were two main reasons for reshoring, according to the survey. Interestingly, one-third of the respondents did not answer this question, possibly indicating a reluctance to discuss the topic due to its sensitive nature.

The survey asked the participating U.S. companies to identify government actions that will accelerate the reshoring process. According to the data, the No. 1 government action that can make a difference is corporate tax reductions; providing tax credits and R&D incentives tied for second place.

Training Courses

ISO 9001 Quality Management

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100 Aviation, Space and Defense

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS 16949 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Phone: 888-572-9642 toll free

Standard Operating Procedures

Walter — Tue, 02 Apr 2013 21:26:44 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business April 2013

This Month

* Standard Operating Procedures

* AS9101:20XX-Why?

* Writing Effective Job Descriptions

* In the News

* Training Courses

Events…

ASQ World Conference on Quality Improvement May 6-8, 2013 Indianapolis, IN. See you there!

Helpful Links…

What We Do

Operational and Quality Systems
Training onsite and online
Lean Enterprise
Six Sigma
Kaizen Events
ITAR
NADCAP
Improved Profits and More!

Connect With Us

If you have any questions regarding the content or have a subject of interest for a future newsletter, please let us know.

Standard Operating Procedures

No matter what type of business you are in, Standard Operating Procedures (SOPs) are critical for establishing and for maintaining standardized work.

A recent survey conducted by Pathwise, showed that up to 25% of respondents have no SOP for writing procedures. An important question to ask yourself is ” Are you dedicating enough resources to your SOPs?”

Highlights of this survey showed:

Roughly 50% of organizations polled do not have formal training on how to write procedures.
It takes the majority of respondents 3-5 days to write a procedure and anywhere from 0-29 days to have the procedure approved. However, for 10% of respondents polled, it takes over 30 days.
On average, irrespective of organization size, the majority of procedures are 1-10 pages in length. However, 25% of organizations that are 1000+ employees in size have procedures averaging 20-50 pages in length.
Roughly 30% of those polled said their procedures contain no process maps.
In an open poll of what other issues are struggled with, the number one response was standardization to how the procedures are written.

Examples of survey participant comments included:

“Since I have no formal training, coming up with the appropriate wording slows me down.”

”We recently bought three more operating companies. It is difficult making the procedures the same without creating an ‘us versus them’ problem.”

“It is difficult when you have to deal with other members of the team who relish complication and politics.”

We need to write our procedures to be compliant with ISO Standards, but flexible enough to allow for programs that do not want the stringency that comes with certain regulations. We are also audited frequently by outside customers who write us up for nuances that they would expect to see in our procedures, so our procedures have become extremely detailed over the years.”

“We struggle with a lack of documentation from the manufacturer and with a lack of equipment on hand to verify the procedure.”

No two management systems are quite the same. Documentation will look different; exclusions are taken for requirements that don’t apply. The number and diversity of procedures, work instructions, and forms, will always vary. Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required.

Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

AS9101:20XX – Why?

We recently attended a workshop conducted by National Quality Assurance (NQA) in Los Angeles, California. NQA is a leading global certification body (CB) providing certification services to many global standards. Our firm received the Associate Consultant Register (ACR) recognition logo from NQA. This recognition is issued as an award to organizations who achieve the qualifications of the ACR program.

One of the presentations we attended was in regards to future changes to AS9101D the Aerospace Standard for Audit Requirements for Aviation, Space and Defense Organizations. The following is information captured regarding this topic currently in Draft Form:

Consolidation of the Forms: “Objective Evidence Record” + “PEAR” = The New PEAR will include both the performance and the conformity assessment results. The New PEAR will be aligned to ISO definition of “Effectiveness”

Other information we captured included:

PEAR will capture objective evidence of conformity (planned activities) and performance (planned results)
Appendices will be referenced as Forms and will not be included in the standard URL link but will be referenced to access the forms. For multi-sites, opening meetings must include a representative from all sites – physically or electronically.
The audit team shall record definitions, targets and values of KPIs related to the audited process on the PEAR. The audit team shall record detailed objective evidence (e.g., reviewed procedures, shop orders, training records, products, verification records) on the PEAR (section 3).
Defined reporting requirements for “combined” and “integrated” audits.
For combined and integrated audits, separate reports shall be issued for each audit performed for each standard.
PEAR(s) will be mandatory and created for each top level process audited to AS91XX series requirements. No longer limited to processes associated with Product Realization requirements.
New Process Evaluation Matrix (PEM)
Clear definitions to assist auditors when determining process effectiveness levels / numerical conclusions when documenting PEAR’s.

Look for further information on future standards and supporting documents in our next newsletter.

Writing Effective Job Descriptions

Management Systems require top management to ensure responsibilities and authorities are defined and communicated within the organization. Properly written job descriptions not only convey responsibilities, they also help with hiring, retention, and legal compliance.

According to the HR Daily Advisor, the do’s and don’ts for worthwhile job descriptions that will really support HR operations include:

Do give specifics. For example, rather than stating that a maintenance worker “keeps up equipment,” it is better to spell out the position’s requirements, which might include performing routine maintenance on assembly machines, including adjusting settings; cleaning and lubricating shafts, gears, and bearings; and dismantling and replacing defective parts, etc.
Do use accurate adjectives.Include adjectives that describe the pace of work (“deadline-driven,” “fast-paced”) or the work environment (“enclosed area,” “noisy setting”), but avoid flowery and overly long descriptions (“cozy but comfortable work environment that encourages creativity”).
DON’T list unreasonable expectations. Most managers hope their employees will exceed their expectations and take on tasks and responsibilities beyond what’s required in the position, but avoid the temptation to include standards that don’t currently apply to this job.
DON’T list excessive qualifications or experience. If you include more than what is needed to competently perform the position, you will end up with bored, overqualified workers and you will limit your ability to place otherwise qualified candidates in the position.
DON’T include anything derogatory or specific about a person who previously held the position.Job descriptions are not the place to air grievances or disappointments about individuals who previously held the position. You can use past experiences to help ensure all necessary information is included, but make sure you describe only the job.
Don’t rely on abbreviations or jargon.A job description should be clear to applicants and employees. Abbreviations and jargon that are specific to your organization, and not to your industry, should be avoided or explained.
Don’t use words that raise a question of discrimination.Avoid language that would be questionable in a job listing. For example, don’t use words such as “youthful” or “able-bodied.”
Don’t use subjective terms.Avoid using words that are subject to differing interpretations. Instead of saying you seek a certain attitude, cooperation, or initiative, describe expected outputs, different constituencies with whom this position interacts, and the nature of those relationships (such as “reports to,” “provides support to,” “supervises”).

In the News

Congratulations to our client, SunDanzer Refrigeration, Inc.

for achieving certification to the ISO 9001:2008 Quality Management System Standard. SunDanzer products include Solar powered refrigerators & freezers in all shapes and sizes.

SAE International Creates Standard for Design Review Based on Failure Modes

SAE International has released the first standard for the quality improvement process known as Design Review Based on Failure Modes (DRBFM).

DRBFM is best described as a quality culture with a foundation of an engineering mindset, according to Bill Haughey, the chairman of the SAE J2886 DRBFM Recommended Practice. DRBFM is modeled after a linkage between a good design review and Failure Mode and Effects Analysis (FMEA). DRBFM is implemented following some type of change – design, test, process or supplier.

DRBFM makes these changes visible by discussing them in depth, identifying every potential failure that impacts quality, cost or delivery. The discussion is technical and supports engineers in making decisions relative to design, test and manufacturing, including the supply base.

SAE International standard ” Design Review Based on Failure Modes (DRBFM)” is now available for purchase on the SAE Website.

Training Courses

ISO 9001 Quality Management

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100 Aviation, Space and Defense

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS 16949 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Phone: 888-572-9642 toll free

AS9101:20XX – Why?

Walter — Wed, 20 Mar 2013 23:48:45 +0000

One of the presentations we attended was in regards to future changes to AS9101D the Aerospace Standard for Audit Requirements for Aviation, Space and Defense Organizations. The following is information captured regarding this topic currently in Draft Form:

Consolidation of the Forms: “Objective Evidence Record” + “PEAR” = The New PEAR will include both the performance and the conformity assessment results. The New PEAR will be aligned to ISO definition of “Effectiveness”

Will capture objective evidence of conformity (planned activities) and performance (planned results)
Appendices will be referenced as Forms and will not be included in the standard URL link but will be referenced to access the forms. For multi-sites, opening meetings must include a representative from all sites – physically or electronically.
The audit team shall record definitions, targets and values of KPIs related to the audited process on the PEAR. The audit team shall record detailed objective evidence (e.g., reviewed procedures, shop orders, training records, products, verification records) on the PEAR (section 3).
Defined reporting requirements for “combined” and “integrated” audits.
For combined and integrated audits, separate reports shall be issued for each audit performed for each standard.
PEAR(s) will be mandatory and created for each top level process audited to AS91XX series requirements. No longer limited to processes associated with Product Realization requirements.
New Process Evaluation Matrix (PEM)
Clear definitions to assist auditors when determining process effectiveness levels / numerical conclusions when documenting PEAR’s.

Look for our next post! We will post further information captured soon on other standards and support documents.

Benchmarking Manufacturing Performance

Walter — Sat, 02 Mar 2013 23:33:58 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business March 2013

This Month

* Benchmarking Manufacturing Performance

* Fraudulent or Counterfeit Parts

* Instruction or Quick Reference?

* Driven By Metrics

* Training Courses

Events…

Aerospace, Defense and Manufacturing Expo March 14, 2013 Phoenix, AZ. We are a Sponsor, Presenter and Exhibitor of this Conference. See you there!

Helpful Links…

What We Do

Operational and Quality Systems
Training onsite and online
Lean Enterprise
Six Sigma
Kaizen Events
ITAR
Improved Profits and More!

Connect With Us

If you have any questions regarding the content or have a subject of interest for a future newsletter, please let us know.

Benchmarking Manufacturing Performance

According to a recent study by the American Productivity & Quality Center (APQC) an international resource for benchmarking and best practices a wide gap exists within American manufacturing companies and their performance effectiveness. Widespread outsourcing of production activities has put tremendous pressure on manufacturing managers to be cost competitive and offer unique customer value. This pressure has intensified the need to produce quality products that are delivered on time, at a competitive price, and with excellent customer service.

The study shows that benchmarking your organization’s manufacturing performance allows you to identify best practices and compare how well your organization is performing in a variety of functional areas.

The following is a representation of what the study found comparing key performance indicators of cost effectiveness, process efficiency, and cycle time.

Make it for less, but don’t forget the customer.

Total cost to manufacture per $1,000 in Revenue: Top Performers ($222), Median Performers ($442), and Bottom Performers ($662).

The amount spent by organizations to manufacture products varies widely. The $430 difference between top and bottom performers in manufacturing cost per $1,000 in revenue represents a potential cost savings of $2.15 billion for an organization with $5 billion in annual revenue. A lower manufacturing cost is desirable for obvious reasons. However, using cost alone as the basis for decision making can have unintended consequences on quality, cycle time, and other strategic concerns. When selecting lower-cost options-including outsourcing-consider how each will ultimately affect customer satisfaction.

Improvement Steps

Organizations can take several concrete steps to help contain the cost to manufacture. Preventative maintenance programs protect investments in equipment, thereby reducing the cost of delays resulting from unscheduled downtime and/or quality slippage. Team members and management can create realistic road maps to cost and quality improvements (think Lean systems and COPQ initiatives). Lastly, motivated employees are more likely to identify cost-cutting, quality-improving opportunities, so take time to develop your employee engagement and training program.

Engaged Employees Are Productive Employees

Value of plant shipments per employee: Top Performers ($453,348), Median Performers ($283,000), and Bottom Performers ($122,189).

In manufacturing, cost alone is not sufficient for evaluating performance. To understand the efficiency of manufacturing processes, a helpful measure is the value of plant shipments per employee. Top performers ship more than $300,000 more product per employee than bottom performers.

Improvement Steps

It is often difficult to motivate employees to contribute ideas and energy to make the factory more productive. Therefore, manufacturing managers should look for new approaches to motivate people and increase employee engagement. Communicating customer expectations and market challenges to all employees prepares them for optimal performance (think performance measurement and visual management systems).

Simpler, more transparent systems that automatically collect and transmit transaction data can speed up performance measurement and the flow of information to internal and external stakeholders. This can lead to faster implementation of performance improvement measures.

Get rid of the unplanned, undesirable, and unproductive.

Unplanned Machine Downtime as a Percentage of Scheduled Run Time: Top Performers (2%), Median Performers (4%), and Bottom Performers (6%).

A multimillion dollar investment in new facilities and equipment can create enormous pressure to get it right in terms of cost, deadlines, and return on investment (ROI). Unplanned downtime can drastically reduce ROI by causing disruptions in quality, cost, and cycle time. The gap between top and bottom performers for this metric is 4 percent of scheduled run time. That unexpected downtime can wreak serious havoc on an organization’s production schedule.

Improvement Steps

Once an organization determines the frequency of such downtime, it can begin tracing and addressing the source or sources of the interruptions (think P.M., Improved Production Resource Planning and Execution). Preventative maintenance programs protect investments in equipment, thereby reducing the cost of delays resulting from unscheduled downtime and/or quality slippage.

If you want to be quick, be flexible.

Manufacturing Cycle Time in Hours: Top Performers (8 hours), Median Performers (24 hours), and Bottom Performers (96 hours).

Manufacturing cycle times vary dramatically. Bottom performers take 88 more hours to produce products than top performers take-a difference of 11 working days.

Improvement Steps

Thanks to lean manufacturing and other process improvement initiatives, many factories have undergone radical transformations in recent years. Long production lines and stacks of work-in-process inventory have been replaced by flexible work cells that pull materials from suppliers and customize products based on individual orders (think value stream mapping, removing process waste). Such efforts have resulted in dramatically reduced lot sizes and manufacturing cycle times. Customizable processes can reduce customer order lead times and yield better returns on invested capital.

To accomplish all of this, manufacturing leaders must establish production schedules, optimum work flows, effective maintenance procedures, and continuous improvement programs that will keep the organization moving forward.

Looking for more information on this study or methods to improve your organizations effectiveness, process efficiency, and cycle time performance? Contact us.

Fraudulent or Counterfeit Parts

Two aerospace standards have been published on fraudulent or counterfeit parts: AS5553:2013 (Revision A) for organizations that procure and/or use electronic parts and AS6081:2012 for distributors of electronic parts.

AS5553A:2013, Fraudulent/Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition

AS5553 is for use by organizations that procure and/or integrate electronic parts and/or assemblies containing such items. The requirements of this standard are generic and intended to be applied/flowed down through the supply chain to all organizations that procure electronic parts and/or assemblies, regardless of type, size and product provided. The mitigation of fraudulent/counterfeit Electrical, Electronic, and Electromechanical (EEE) parts in this standard is risk-based and will vary depending on the desired performance or reliability of the equipment/hardware.

AS6081:2012, Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition – Distributors

AS6081 standardizes practices to:

Identify reliable sources to procure parts
Assess and mitigate risk of distributing fraudulent/counterfeit parts
Control suspect or confirmed fraudulent/counterfeit parts
Report suspect and confirmed fraudulent/counterfeit parts to other potential users and the “authority having jurisdiction”

AS5553A:2013 and AS6081:2012 can be ordered at the SAE website.

Instruction or Quick Reference?

A “cheat sheet” is a concise set of notes used for quick reference. In the academic world, cheat sheets are so named because they may be used by students without the instructor’s knowledge to cheat on a test.

In the business world, so called “cheat sheets or reference document” are popular in any setting where a quick reference is useful. New employees often make notes on how to perform their job, especially if written instructions aren’t available, supplied instructions are incomplete or complex, or the job training was inadequate. These personal job notes may be also referred to as cheat sheets.

On the surface, use of cheat sheets would seem to be helpful and may even be encouraged. However, these job notes may not accurately describe the tasks, may be in conflict with written instructions, or be unapproved by management. ISO 9001:2008, clause 4.2.3 states that “Documents required by the quality management system shall be controlled.” So, if cheat sheets are needed by employees to carry out their activities, these cheat sheets would be viewed as documents that must be controlled.

To control a document means it must be approved prior to use, updated as necessary and re-approved, and identified with the current revision status. Cheat sheets become authorized documents if they are controlled. If not, auditors will write them up as nonconformities.

Employees do not like their cheat sheets being called nonconformities, especially if the corrective action is to just discard the cheat sheets. The existence of cheat sheets may indicate they are needed, so simply removing them might be a mistake.

Instead, find out why some employees need the cheat sheets/reference document and take the appropriate action, e.g., improve training, provide mentoring, add the cheat sheets as controlled documents, or include the reference information in existing documents.

Audits correctly spot the use of these reference items. Make sure your response supports the employees by providing alternative support.

Driven by Metrics

Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitor’s measure, what is read in the business press and what benchmarked firms are using.

The best organizational metrics keep the focus on its strategic direction, not the direction in which others are going.

The types of metrics and the right mix of metrics drives effective outcomes. For example, some metrics should focus on customer needs (externally focused, effectiveness metrics) and some on organizational needs (internally focused, efficiency metrics) so the organization can effectively balance the management of resources used to achieve the market results. An organization with high customer satisfaction and costs that create negative profitability is not going to be a sustainable venture.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance management process. As much as possible, metrics should be biased toward business drivers, such as process or leading indicators, instead of outcomes.

Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:

Who owns the metric?
Where will the data be acquired and how often?
How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time?
How often should the metrics be reported and analyzed for decision making?

Although it might sound simple, creating operational definitions is an important component of metric details. What is meant by the terms as expressed in mathematical terms (for example, numerator, and denominator and time boundaries)? A company might ask, “What is meant by on-time delivery?” When it is picked up by the carrier or when it arrives at the target location? Clear measurement and accurate definitions are important to an organizations success.

Training Courses

ISO 9001 Quality Management

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100 Aviation, Space and Defense

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS 16949 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Phone: 888-572-9642 toll free

Small and medium-sized enterprises share standard success stories

Walter — Thu, 21 Feb 2013 13:48:02 +0000

How do small and medium-sized enterprises (SMEs) compete on a level playing field with the biggest business? Quite simply: by applying International Standards.

It is estimated that more than 90 % of the world’s businesses are SMEs. Surprised? Don’t be. SMEs are, on average, the businesses that are generating growth, creating jobs, growing faster and innovating more. More importantly, they are a good deal less complicated (structurally) and more efficient and flexible than are large firms. International Standards provide as many benefits for small businesses as they do for global enterprises. Their strategic use can make a significant difference to the annual turnover of an SME, sometimes the difference between success and failure.

Given the trend towards outsourcing activities and the growing importance of cooperation in the value chain, effective Management System Standard implementation by SMEs is of key importance in facilitating trade and promoting sustainable development.

Read on and discover why International Standards are of strategic economic importance, and how SMEs (despite all obstacles) stand to gain most from their use. See the February issue of ISO Focus which highlights the importance of International Standards to the company.

Salvaging Customer Service

Walter — Tue, 05 Feb 2013 00:19:18 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business February 2013

This Month

* Salvaging Customer Service

* Sales First For Manufacturers

* Operational and Quality System Design

* In the News

* Training Courses

Events…

Aerospace, Defense and Manufacturing Expo March 14, 2013 Phoenix, AZ. We are a Sponsor, Presenter and Exhibitor of this Conference.

ASQ Lean and Six Sigma Conference March 4-5, 2013 Phoenix, AZ

Helpful Links…

What We Do

Operational and Quality Systems
Training onsite and online
Lean Enterprise
Six Sigma
Kaizen Events
ITAR
Improved Profits and More!

Connect With Us

If you have any questions regarding the content or have a subject of interest for a future newsletter, please let us know.

Salvaging Customer Service

Recent surveys by Harris Interactive and Accenture show missed opportunities for companies to resolve problems, strengthen processes, improve products and offerings, and learn from customers, all in the name of retaining them.

Complaining customers tell you where your processes are failing and you are probably alienating 10 times as many customers who are simply not telling you, costing you a huge amount of revenue. Customer service problems will persist, but there are ways to resolve issues.

Consider some highlights, or perhaps lowlights, from these surveys:

Organizations admit managing customer expectations and communicating with customers are top challenges, but most organizations don’t see doing these things as a top priority and are more likely to invest resources in other areas of operation.
More repeat customers said they believe they’re being treated like strangers because customer service representatives don’t know the customers’ histories with the organization.
More than two-thirds of customers who switched providers because of an issue said they would have stayed with the company if the matter had been resolved during their first contact with the company’s customer service department.

The Harris Interactive survey also showed that consumers who used social media reacted more negatively to poor service: Nearly three-quarters said they decided not to buy a product or service because of a negative experience with a sales representative.

It seems there are plenty of ways for organizations to shore up their customer service deficiencies. Some of the advice seems obvious, but organizations still aren’t taking to heart the message experts keep offering:

Treat the customer more like a partner and not simply a participant in the product transaction.
Form a rapid response team charged with identifying and resolving customer service issues.
Systematize responses to customer complaints, perhaps using root cause analysis. Analyze failures to see whether systematic issues can be resolved.
Educate product teams on what customer expectations are and what the team’s priority should be.
Share survey analysis with upper management so it can support changes in product and service delivery.
Address customer issues in a timely manner.

Enhancing customer service means investing in resources to have information and data available for customer service representatives to use and be able to interact intelligently when customers call. This includes training those on the front lines to handle these connections more carefully.

Most Think Sales First for Manufacturers

Nearly 60% of consumers polled in a recent global survey said they think manufacturers value sales more than product safety. Only 36% said they strongly believe manufacturers perform thorough product safety testing before introducing new products to the market.At the same time, manufacturers realize product safety is increasing in importance to consumers and delivering it is critical to their business success, according to findings from the second annual Underwriters Laboratories (UL) study.

Manufacturers ranked quality as the No. 1 most important driver of their success today and the No. 1 most important future driver.

Quality was also a main topic in the “Product Mindset 2012″ study, which was the culmination of interviews with 1,201 consumers and 1,202 manufacturers in China, Germany, India and the United States.

Manufacturers also said they think consumers care most about quality, with 38% saying it is the most important issue for consumers. For consumers, quality ranked as the first or second most important type of product information across the food, building materials, high-tech and smart appliance categories.

To read and download the full study go to the UL Product Mindset Website.

Operational and Quality System Design

A critical question that many organizations face when starting a documented operational and quality management system or improving a current one is “How much documentation is required?”

If you’re a quality systems veteran, you remember the ISO 9001, 1987 and 1994 versions lead to a number of ‘documented procedures’ as part of the standard’s 20 requirements. Such an approach did lead to organizations putting effort into creating documentation which often didn’t add value and was not easily understood by employees or customers. This was reduced with the ISO 9001:2000/2008 revision, specifying just 6 documented procedures, although implementers are given the latitude to define more as they see fit.

We find today in many cases that lessons learned from past year’s experiences is driving a “less is more” when it comes to management systems documentation. If we cannot rely on an ISO standard telling us where and how much documentation to write, what can we base our decision on?

Can your organization run effectively on six procedures? Do we base it on:

A friends documentation given to us to copy from another organization?
A canned template software program “ISO kits” found on the Internet?
The two page Quality Manual (or is that 4 pages?) a consulting firm is selling you?

The answer is in the risk associated with needing to control your business processes. What is the risk of a certain system or process not being controlled? Many factors come into play: personnel experience, competencies, turnover, task complexity, customer and regulatory requirements are just some to be considered.

Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required. Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

Interested in extended risk management information and/or developing a custom approach to your documented operational and quality management system? Contact us.

In the News

Security and Service Management

ISO and IEC have published a new International Standard giving organizations advice on how to make integrated use of information security and service management system standards.

The new ISO/IEC 27013:2012, Information technology – Security techniques – Guidance on the integrated implementation of ISO/IEC 27001 and ISO/IEC 20000-1, provides guidance to be used whether one standard is implemented before the other, or both standards are implemented simultaneously.

The publication of ISO/IEC 27013 arose from the recognition that combining use of both International Standards brings additional benefits. ISO/IEC 27013 gives guidance on the first steps to be taken by organizations that wish to increase efficiency, improve their information security, service management and services.

For more information on this visit the ISO Website.

How to Publicize Your ISO Certification

The ISO.org website contains comprehensive information on how to promote your company certification. These guidelines provide useful information in preparing promotional and communication material such as press releases, advertisements, marketing brochures, videos, staff announcements, logos, slogans and catch lines for diverse media ranging from print and broadcasting, to Internet and multi-media applications, to product labels, signs, banners, vehicle fleets and so on.

To download the PDF version visit the ISO Website.

Training Courses

ISO 9001 Quality Management

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100 Aviation, Space and Defense

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS 16949 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Phone: 888-572-9642 toll free